FDA 510(k)

IceSense 3, ProSense, MultiSense

K-Number: K183213 · 2019-12-20

Decision Date2019-12-20

Product CodeGEH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

IceSense 3, ProSense, MultiSense is a medical device manufactured by IceCure Medical , Ltd.. It received FDA 510(k) clearance on 2019-12-20 under approval number K183213. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IceSense 3, ProSense, MultiSense?

IceSense 3, ProSense, MultiSense is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by IceCure Medical , Ltd.. The 510(k) number is K183213.

When was IceSense 3, ProSense, MultiSense approved by the FDA?

IceSense 3, ProSense, MultiSense received FDA 510(k) clearance on 2019-12-20, under approval number K183213.

What company makes IceSense 3, ProSense, MultiSense?

IceSense 3, ProSense, MultiSense is manufactured by IceCure Medical , Ltd..

What is the FDA product code for IceSense 3, ProSense, MultiSense?

The FDA product code for IceSense 3, ProSense, MultiSense is GEH.

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Official Source

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